Spinal correction construct and method

ABSTRACT

A spinal construct includes at least one body including a first biasing member engageable with a longitudinal element for translation thereof relative to the body in a first direction. A second biasing member is engageable with a lock. The lock is connected with the longitudinal element to resist and/or prevent translation of the longitudinal element relative to the body in a second direction. Implants, surgical instruments, systems and methods are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and a method for correction of a spine disorder.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degeneration caused bydevelopmental conditions, injury and aging. Spinal disorders typicallyresult in symptoms including deformity, pain, nerve damage, and partialor complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. Correction treatments used for positioning andalignment may employ implants such as rods, tethers and bone screws forstabilization of a treated section of a spine. This disclosure describesan improvement over these prior technologies.

SUMMARY

In one embodiment, a spinal construct is provided. The spinal constructincludes at least one body including a first biasing member engageablewith a longitudinal element for translation thereof relative to the bodyin a first direction. A second biasing member is engageable with a lock.The lock is connected with the longitudinal element to resist and/orprevent translation of the longitudinal element relative to the body ina second direction. In some embodiments, implants, surgical instruments,systems and methods are disclosed.

In one embodiment, a method for treating a spinal disorder is provided.The method includes the steps of: disposing an expandable spinalconstruct in a selected configuration; fixing the spinal construct inthe selected configuration with a member; attaching a first end of thespinal construct with tissue; attaching a second end of the spinalconstruct with tissue; and disengaging the member from the spinalconstruct to release the spinal construct from the selectedconfiguration.

In one embodiment, the method includes the steps of: attaching a firstend of a spinal construct with tissue, the spinal construct including aplurality of bodies, each body including a biasing member engageablewith a longitudinal element for translation relative to the body toexpand the spinal construct; and attaching a second end of the spinalconstruct with tissue and disposing the plurality of bodies in aselected orientation with tissue to create at least one zone oftreatment with the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a cross section view of the components shown in FIG. 1;

FIG. 3 is an end view of the components shown in FIG. 1;

FIG. 4 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 5 is a cross section view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 6 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 7 is a plan view of the components shown in FIG. 6;

FIG. 8 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 9 is a plan view of the components shown in FIG. 8;

FIG. 10 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 11 is a break away view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 12 is a cross section view of the components shown in FIG. 11;

FIG. 13 is a cross section view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 14 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 15 is a cross section view of the components shown in FIG. 14; and

FIG. 16 is an exploded view of the components shown in FIG. 15.

DETAILED DESCRIPTION

The exemplary embodiments of the system and related methods of usedisclosed are discussed in terms of medical devices for the treatment ofmusculoskeletal disorders and more particularly, in terms of a surgicalsystem and method for treatment of a spine disorder. In some embodiment,the present system and method can be employed to treat scoliosis in agrowing child and utilize a spinal construct, which may include, forexample, growing rods, vertical expandable prosthetic titanium ribs,Shilla technique components, vertebral body stapling and/or tethers. Insome embodiments, the present system and method can include limitationsbased on type and magnitude of spinal deformity effectively treated, ageof a patient, and underlying co-morbidities, which may impact outcome.

In some embodiments, the surgical system includes a spinal constructhaving a self-distracting rod. In some embodiments, the surgical systemis configured to distract the spine without fusion to preventprogression of a spinal curvature while allowing a thoracic capacity ofa child to develop. In some embodiments, the self-distracting rod isconfigured to resist and/or prevent a need for surgeries every sixmonths. In some embodiments, the surgical system is inexpensive, simpleand avoids manipulated distraction.

In some embodiments, the surgical system includes a self-distracting rodhaving a lock with a tapered crimp configuration. In some embodiments,the surgical system includes a self-distracting rod having a biasingmember, such as, for example, a follower and a spring configured tomaintain a load on the rod by removing slack in the spinal construct.

In some embodiments, the surgical system includes a self-distracting rodthat is configured to prevent forcing correction of the spine andprovides for natural growth. In some embodiments, the surgical system isconfigured to facilitate screw placement and correction of the spine. Insome embodiments, the surgical system includes a self-distracting rodhaving bearings configured to translate along a taper of a lock. In someembodiments, translation along the taper causes the bearings to apply aforce to the rod to prevent the rod from backing up while allowing therod to extend and/or expand the spinal construct and the spine to grow.

In some embodiments, the spinal construct includes a follower springconfigured to apply a force against the rod. In some embodiments, thesurgical system includes a self-distracting rod configured to facilitategrowth while maintaining a load on the spine without repeated surgeriesor doctor visits. In some embodiments, the surgical system includes aself-distracting rod having a locking mechanism configured to facilitateand guide growth while the follower spring applies pressure combiningboth growth guidance and distraction.

In some embodiments, the surgical system includes a self-distracting rodincluding for example, ball bearings, a body, an extending rod and abiasing member having a lock mechanism. In some embodiments, thesurgical system includes a self-distracting rod having a follower springconfigured to apply a pressure to the rod to generate force.

In some embodiments, the force that pushes on the extending rod isgenerated by a constant pressure. In some embodiments, the surgicalsystem includes a self-distracting rod having a high pressure chamberand a low pressure chamber with a one-way valve disposed therebetween.In some embodiments, a constant pressure is maintained in the lowerpressure chamber as the volume changes thereby causing a constant forceon the rod.

In some embodiments, the surgical system includes a spinal constructhaving one or more self-distracting rods configured to provideconcurrent extension. In some embodiments, the surgical system includesa spinal construct having at least two self-distracting rods configuredfor disposal in sequence to increase an extended length, increase force,and allow for rod contouring between the two rod mechanisms. In someembodiments, the spinal construct includes at least two self-distractingrods each having a different spring force. In some embodiments, thediffering forces of the self-distracting rods facilitate distraction ofa thoracic spine at a different rate than a lumbar spine to resistand/or prevent kyphosis of the spine. In some embodiments, the spinalconstruct includes a body having at least two self-distracting rods andthe body can be made of different materials to change the stiffness ofthe construct. In some embodiments, the spinal construct includes afirst self-distracting rod having a flexible configuration relative to asecond self-distracting rod.

In some embodiments, the surgical system includes a self-distracting rodconfigured to provide opposed distraction. In some embodiments, thesurgical system includes at least two self-distracting rods being fixedto an apex of the spine to correct an apex curvature, while allowing andguiding growth and maintaining a constant force on the spine. In someembodiments, the surgical system includes a self-distracting rod tofacilitate derotation.

In some embodiments, the surgical system includes a self-distracting rodhaving a release mechanism. In some embodiments, the release mechanismis configured to facilitate delivery of the self-distracting rod to anoperating room in a compressed and/or non-extended configuration suchthat the rod can be activated to grow without putting an unexpected loadon the spine.

In some embodiments, the surgical system is configured for assembly in acompressed orientation and a coupling member, such as, for example, aset screw is engaged with the rod to hold the rod in place. In someembodiments, the set screw is released intra-operatively, slowly in acontrolled manner so that no unexpected forces are placed onto thespine. In some embodiments, the surgical system includes a rod that isconfigured to threadingly engage a body to resist and/or preventextension of the rod from the body until insertion at a surgical site.

In some embodiments, the surgical system includes a lock that isconfigured to facilitate extension of the spinal construct whileresisting and/or preventing restriction of the spinal construct. In someembodiments, the lock can disengage to allow for growth. In someembodiments, the surgical system includes a mechanism that applies aforce to an extending rod to maintain a constant force on the spine byfollowing the growth of the spine. In some embodiments, the surgicalsystem includes an intra-operative release mechanism to initiateextension of the rod in a safe and controlled manner. In someembodiments, the surgical system provides for flexibility of placementto be used in distraction techniques, growth guidance techniques, orcombinations of the two techniques. In some embodiments, the surgicalsystem may include force sensors configured to measure a force on thespine and provide feedback to the surgeon. In some embodiments, thesurgical system includes a release mechanism that is configured toresorb at precise time periods to initiate a subsequent phase of growth.In some embodiments, the surgical system includes rods having a lowfriction and/or low wear material to eliminate wear debris.

In some embodiments, the surgical system includes a spinal constructthat distracts the spine without fusion to prevent progression of aspinal curve while allowing a thoracic capacity of the child to develop.In some embodiments, the surgical system avoids the need for surgeriesevery six months to adjust the spinal construct. In some embodiments,the spinal construct includes a body having three bearings configured totranslate along a taper of a lock that collapses on the rod and resistsand/or prevents the rod from backing up, while allowing the rod to grow.In some embodiments, the spinal construct includes a follower and aspring configured to apply a force to the rod. In some embodiments, thespinal construct is configured to allow growth, but maintain a load onthe spine without repeated surgeries or doctor visits.

In some embodiments, one or all of the components of the presentsurgical system may be disposable, peel-pack, pre-packed steriledevices. One or all of the components of the surgical system may bereusable. The surgical system may be configured as a kit with multiplesized and configured components.

In some embodiments, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the present disclosure may be employed with other ostealand bone related applications, including those associated withdiagnostics and therapeutics. In some embodiments, the disclosed systemmay be alternatively employed in a surgical treatment with a patient ina prone or supine position, and/or employ various surgical approaches tothe spine, including anterior, posterior, posterior mid-line, directlateral, postero-lateral, and/or antero lateral approaches, and in otherbody regions. The present disclosure may also be alternatively employedwith procedures for treating the lumbar, cervical, thoracic and pelvicregions of a spinal column. The system and methods of the presentdisclosure may also be used on animals, bone models and other non-livingsubstrates, such as, for example, in training, testing anddemonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. As used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, vessels, ligaments,tendons, cartilage and/or bone unless specifically referred tootherwise.

The following discussion includes a description of a surgical systemincluding spinal constructs, implants, surgical instruments, relatedcomponents and methods of employing the system in accordance with theprinciples of the present disclosure. Alternate embodiments aredisclosed. Reference is made in detail to the exemplary embodiments ofthe present disclosure, which are illustrated in the accompanyingfigures. Turning to FIGS. 1-3, there are illustrated components of asurgical system, such as, for example, a spinal correction system 10.

The components of spinal correction system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal correctionsystem 10, individually or collectively, can be fabricated frommaterials such as stainless steel alloys, aluminum, commercially puretitanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, superelastic metallic alloys (e.g.,Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics andcomposites thereof such as calcium phosphate (e.g., SKELITE™),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations. Various components of spinal correction system 10may have material composites, including the above materials, to achievevarious desired characteristics such as strength, rigidity, elasticity,compliance, biomechanical performance, durability and radiolucency orimaging preference. The components of spinal correction system 10,individually or collectively, may also be fabricated from aheterogeneous material such as a combination of two or more of theabove-described materials. The components of spinal correction system 10may be monolithically formed, integrally connected or include fasteningelements and/or instruments, as described herein.

Spinal correction system 10 is employed, for example, with an open ormini-open, minimal access and/or minimally invasive includingpercutaneous surgical technique and includes one or more spinalconstructs for a correction treatment at a surgical site within a bodyof a patient, for example, a section of a spine to treat various spinepathologies, such as, for example, adolescent idiopathic scoliosis andScheuermann's kyphosis. In some embodiments, the components of spinalcorrection system 10 are configured to deliver and introduce componentsof a spinal construct 12 that includes implants, such as, for example,one or more spinal rods, bodies, sleeves, connectors and/or fasteners.Spinal construct 12 forms one or more components of a correctiontreatment and/or correction system 10 implanted with tissue forpositioning and alignment to stabilize a treated section of vertebrae.

Spinal construct 12 includes a body having a sleeve 14. Sleeve 14defines a longitudinal axis X1. Sleeve 14 extends between an end 16 andan end 18. In some embodiments, sleeve 14 has a tubular cross section.In some embodiments, sleeve 14 may have an oval, oblong, triangular,square, rectangular, polygonal, irregular, uniform, non-uniform, offset,staggered, undulating, arcuate, variable and/or tapered configuration.Sleeve 14 includes an outer surface 20.

The body of spinal construct 12 includes a rod 30 extending from end 18.Rod 30 extends between an end 32 and an end 34. In some embodiments, end32 is monolithically formed with sleeve 14. In some embodiments, rod 30is integrally connected or includes fastening elements for connectionwith sleeve 14. In some embodiments, outer surface 20 tapers between end18 and rod 30 such that rod 30 includes a smaller dimension, such as,for example, a diameter or thickness, than sleeve 14. In someembodiments, sleeve 14 and/or rod 30 may have a uniformthickness/diameter. In some embodiments, sleeve 14 and/or rod 30 mayhave various surface configurations, such as, for example, rough,threaded for connection with surgical instruments, arcuate, undulating,dimpled, polished and/or textured. In some embodiments, a dimensiondefined by sleeve 14 and/or rod 30 may be uniformly increasing ordecreasing, or have alternate dimensions along its length. In someembodiments, sleeve 14 and/or rod 30 may have various lengths. End 34 isconfigured for engagement with tissue and/or a spinal implant, such as,for example, a bone fastener, as described herein.

Sleeve 14 includes an inner surface 40 that defines a cavity, such as,for example, a passageway 42. Passageway 42 extends axially withinsleeve 14. In some embodiments, passageway 42 may extend within sleeve14 at alternate orientations, relative to sleeve 14, such as, forexample, arcuate, transverse, perpendicular and/or other angularorientations such as acute or obtuse, coaxial and/or may be offset orstaggered.

Passageway 42 includes an opening 44 adjacent end 16. Passageway 42 andopening 44 are configured for movable disposal of a longitudinalelement, such as, for example, a spinal rod 50, as described herein. Rod50 is configured to translate within passageway 42 relative to sleeve14, as described herein. In some embodiments, rod 50 is configured fordynamic axial translation relative to sleeve 14, as described herein.Passageway 42 has a circular cross section. Surface 40 defines a cavity46 for disposal of a portion of a lock 70, as described herein, and atapered portion 48 for engagement with lock 70. In some embodiments,tapered portion 48 may include a constant taper throughout a length. Insome embodiments, tapered portion 48 extends along a discrete length ofsleeve 14. In some embodiments, tapered portion 48 includes asubstantially continuous slope, or may include different slopes alongthe length.

In some embodiments, passageway 42 may have alternate cross sectionconfigurations for disposal of alternately shaped spinal rods, such as,for example, oval, oblong, triangular, square, polygonal, irregular,uniform, non-uniform, offset, undulating, arcuate, variable and/ortapered. In some embodiments, inner surface 40 may define cross sectionconfigurations, such as, for example, mating, engaging and/or differentfrom the cross section of one or more spinal rods disposed withinpassageway 42 such that sleeve 14 may limit, resist and/or preventrotational movement of the one or more spinal rods relative to sleeve14.

Rod 50 extends between an end 52 and an end 54. Rod 50 includes asurface 56 engageable with an inner surface of lock 70 to facilitatetranslation of rod 50 relative to sleeve 14 in a first direction and toresist and/or prevent translation of rod 50 in a second direction, asdescribed herein. In some embodiments, rod 50 includes a smallerdimension, such as, for example, a diameter or thickness, than sleeve14. In some embodiments, rod 50 may have a uniform thickness/diameter.In some embodiments, rod 50 may have various surface configurations,such as, for example, rough, threaded for connection with surgicalinstruments, arcuate, undulating, dimpled, polished and/or textured. Insome embodiments, rod 50 may be equivalent to the size of rod 30. Insome embodiments, rod 50 may be a different size, such as, for example,having a different diameter than rod 30. In some embodiments, rod 50 maybe an alternate material than rod 30. In some embodiments, a dimensiondefined by rod 50 may be uniformly increasing or decreasing, or havealternate dimensions along its length. In some embodiments, rod 50 mayhave various lengths. End 52 is configured for engagement with tissueand/or a spinal implant, such as, for example, a bone fastener, asdescribed herein.

End 54 is configured for disposal within passageway 42. End 54 includesa surface 58 configured for connection with a biasing member 60, asshown in FIG. 2. Biasing member 60 includes a coil spring 62 and afollower 64. Follower 64 is configured for moveable disposal withinsleeve 14 and driven or urged in a selected direction under the biasforce of spring 62 to facilitate translation of rod 50, as describedherein. In some embodiments, such translation of rod 50 includesexpansion of spinal construct 12 under the bias force of spring 62 toprovide a constant pressure to rod 50 for growth guidance anddistraction. In some embodiments, follower 64 includes a T-shaped crosssection. In some embodiments, follower 64 comprises a piston. In someembodiments, the biasing member may include an elastomeric member, clip,leaf spring, gravity induced configuration, pneumatic configuration,hydraulic configuration and/or manual lever. In some embodiments,follower 64 is connected with end 54 by a pin 66. In some embodiments,follower 64 is monolithically formed with end 54. In some embodiments,follower 64 is integrally connected or includes fastening elements forconnection with end 54.

Spring 62 is disposed within sleeve 14 and extends between a surface 63of sleeve 14 and a surface 68 of follower 64. In some embodiments,surface 63 is fixed and surface 68 is moveable relative to sleeve 14. Insome embodiments, spring 62 extends about an extension 69 of follower64. Spring 62 applies a force and/or load to surface 68 causing follower64 to drive and/or urge rod 50 in a direction, as shown by arrow A inFIG. 2. As such, rod 50 is urged to expand spinal construct 12 under aconstant force of spring 62. In some embodiments, spring 62 facilitatesdynamic translation of rod 50 during growth. Dynamic translation of rod50 allows spinal construct 12 to respond to an active and/or changingspine. For example, as forces and/or force changes are applied to spinalconstruct 12, such as, for example, patient growth, trauma anddegeneration, and/or system 10 component creep, deformation, damage anddegeneration, one or more components of spinal construct 12, forexample, sleeve 14, rod 50 and biasing member 60 adapt and/or arecontinuously adjustable with a responsive force to maintain the appliedforce transmitted from the bone fasteners substantially constant.

In some embodiments, the dynamic biasing force of spring 62 facilitatesa self-distracting spinal construct 12. Translation of rod 50 allowsspinal construct 12 to selectively adjust its length to accommodategrowth to avoid multiple surgeries. In some embodiments, spinalconstruct 12 includes one or more components, as described herein,disposed in a selected orientation, as described herein, to guide growthalong a selected path, while maintaining a load on the spine.

Rod 50 is engageable with lock 70. Lock 70 includes a sleeve 72. Sleeve72 includes an inner surface 74 that defines a cavity, such as, forexample, a passageway 76. Rod 50 extends through passageway 76. Sleeve72 includes a surface 78 that defines three openings 80 disposed in aspaced apart relation about sleeve 72. Openings 80 are equidistantly andcircumferentially disposed about sleeve 72 for communication withpassageway 76. In some embodiments, surface 78 defines one or aplurality of openings 80.

Openings 80 are configured for disposal of bearings 82. Bearings 82 areconfigured to roll and/or slide between surface 56 and tapered portion48 to facilitate translation of rod 50 relative to sleeve 14 in adirection, as shown by arrow A in FIG. 2, and/or expansion of thecomponents of spinal construct 12. In some embodiments, rod 50 istranslatable relative to sleeve 14 and/or the components of spinalconstruct 12 are expandable in a non-locking orientation of spinalconstruct 12.

Upon translation of rod 50 relative to sleeve 14 in a direction, asshown by arrows B in FIG. 2 and/or compression/contraction of thecomponents of spinal construct 12, bearings 82 slide/roll into a morenarrow space between surfaces 56, 48 for an interference and/orfrictional engagement therewith to compress and/or crimp rod 50 withtapered portion 48 to resist and/or prevent translation of rod 50relative to sleeve 14 in a direction, as shown by arrows B in FIG. 2and/or compression/contraction of the components of spinal construct 12,as described herein. In some embodiments, translation of rod 50 relativeto sleeve 14 and/or compression/contraction of the components of spinalconstruct 12 is resisted and/or prevented in a locked orientation ofspinal construct 12. In some embodiments, lock 70 is disengageable orremovable from a locked orientation. In some embodiments, lock 70 isfixed in a locked orientation. In some embodiments, biasing member 60and lock 70 are engageable with rod 50 and comprise a strut to resistand/or prevent compression/contraction of the components of spinalconstruct 12 in a direction, as shown by arrows B in FIG. 2.

Lock 70 includes a flange 90 circumferentially disposed about sleeve 72.Flange 90 includes a surface 92. Cavity 44 is configured for disposal ofa portion of lock 70, which includes a biasing member, such as, forexample, a wave spring 94, as shown in FIG. 2. In some embodiments, thebiasing member of lock 70 may include an elastomeric member, clip, coilspring, leaf spring, gravity induced configuration, pneumaticconfiguration, hydraulic configuration and/or manual lever.

Spring 94 applies a force and/or load to surface 92 to drive and/or urgelock 70 in a direction, as shown by arrow B in FIG. 2, stabilizingmotion and/or positioning of lock 70 with passageway 42. In someembodiments, spring 94 drives and/or urges lock 70 to a lockedorientation of spinal construct 12. In some embodiments, a stop element,such as for example, a ring 96 is disposed with sleeve 14 to enhancelocking and/or facilitate disposal in a locked orientation of spinalconstruct 12. In some embodiments, lock 70 includes a range of movementand ring 96 comprises a limit to facilitate limitation of translation ofrod 50 in a direction, as shown by arrow B in FIG. 2.

In some embodiments, spinal construct 12 prevents axial migration of rod50 while maintaining a dynamically movable configuration of rod 50. Insome embodiments, rod 50 may include a dynamically axially translatableconfiguration, as described herein, and spinal construct 12 may beconfigured, as described herein, such that spinal construct 12 maylimit, resist and/or prevent movement in at least one direction of rod50 relative to sleeve 14. Translation of bearings 82 along taper portion46 facilitates locking and unlocking of lock 70 relative to rod 50.

In some embodiments, spinal construct 12 includes a fastener, such as,for example, a bone fastener 120 that is fastened with vertebrae V, asshown in FIG. 4. In some embodiments, spinal construct 12 may includeone or a plurality of fasteners. In some embodiments, one or more ofbone fasteners 120 may be engaged with tissue in various orientations,such as, for example, series, parallel, offset, staggered and/oralternate vertebral levels. In some embodiments, one or more fastenersmay comprise multi-axial screws, sagittal angulation screws, pediclescrews, mono-axial screws, uni-planar screws, facet screws, fixedscrews, tissue penetrating screws, conventional screws, expandingscrews, wedges, anchors, buttons, clips, snaps, friction fittings,compressive fittings, expanding rivets, staples, nails, adhesives,posts, fixation plates and/or posts.

Bone fastener 120 comprises a head 122 and an elongated shaft 124configured for penetrating tissue. Head 122 includes a receiving portionconfigured for disposal of a longitudinal element, such as, for example,a spinal rod, for example, a rod 30 and/or a rod 50. Rods 30, 50 areattached with and extend along a posterior portion of vertebrae V.

In some embodiments, rod 30 and/or rod 50 are connected with heads 122causing a tension in rods 30, 50 and/or vertebrae V. In someembodiments, the spinal construct, for example, rods 30, 50 and/or atension thereof is employed to displace, pull, twist or align vertebraeV as part of a correction system and treatment. In some embodiments, end52 of rod 50 is fixed with at least one vertebra and end 54 isdynamically moveable within passageway 42. In some embodiments, end 34of rod 30 is fixed with at least one vertebra.

In some embodiments, spinal construct 12 may include one or moretethers. In some embodiments, rod 30, rod 50 and/or a tether can have aflexible configuration, which includes movement in a lateral or side toside direction and prevents expanding and/or extension in an axialdirection upon fixation with vertebrae. In some embodiments, all or onlya portion of rod 30, rod 50 and/or a tether may have a semi-rigid,rigid, flexible or elastic configuration, and/or have elastic and/orflexible properties such as the elastic and/or flexible propertiescorresponding to the material examples described herein. Rod 30, rod 50and/or a tether can include a plurality of separately attachable orconnectable portions or sections, such as bands or loops, or may bemonolithically formed as a single continuous element.

In assembly, operation and use, as shown in FIG. 4, spinal correctionsystem 10, similar to the systems and methods described herein, includesspinal construct 12 and is employed with and/or subsequent to a surgicalcorrection procedure, similar to those described herein. Spinalcorrection system 10 may be employed in surgical procedures for treatingdisorders of the spine, such as, for example, a correction treatment totreat child/adolescent idiopathic scoliosis and/or Scheuermann'skyphosis of a spine. In some embodiments, one or all of the componentsof spinal correction system 10 can be delivered as a pre-assembleddevice or can be assembled in situ.

The surgical correction treatment including spinal construct 12 is usedfor correction and alignment in stabilization of a treated section ofvertebrae V. In use, to create tension along vertebrae V with rods 30,50, a medical practitioner obtains access to a surgical site includingvertebrae V via a posterior surgical approach. In some embodiments, thesurgical site may be accessed in any appropriate manner, such as throughincision and retraction of tissues. In some embodiments, spinalcorrection system 10 can be used in any existing surgical method ortechnique including open surgery, mini-open surgery, minimally invasivesurgery and percutaneous surgical implantation, whereby vertebrae V isaccessed through a mini-incision, or sleeve that provides a protectedpassageway to the area.

In some embodiments, spinal construct 12 includes one or morecomponents, as described herein, disposed in a selected orientation, asdescribed herein, to guide growth along a selected path and/ororientation along vertebrae V, while maintaining a force and/or load onvertebrae V. In some embodiments, one or more components of spinalconstruct 12 are disposed in a selected orientation, as describedherein, to create one or more zones of treatment along vertebrae V. Forexample, spinal construct 12 can have at least two distracting bodies,as described herein, disposed in sequence to create a treatment zonethat increases an extended length, increases force and/or allows for rodcontouring. In another example, spinal construct 12 can have at leasttwo distracting bodies, as described herein, having a different springforce such that the differing forces create treatment zones thatfacilitate distraction of thoracic vertebrae at a different rate thanlumbar vertebrae to resist and/or prevent kyphosis of vertebrae V. Inanother example, spinal construct 12 can have at least two distractingbodies, as described herein, made of different materials to createtreatment zones having alternate stiffness and/or flexibility. In someembodiments, the materials of the bodies of spinal construct 12 may haveflexible properties, such as the flexible properties corresponding tothe material examples described above, and/or may have a semi-rigid,rigid or elastic configuration, and/or have elastic properties, such asthe elastic properties corresponding to the material examples describedabove. In another example, spinal construct 12 can have one or morebodies, as described herein, which create one or more treatment zones toprovide opposed distraction. In another example, spinal construct 12 canhave at least two distracting bodies, as described herein, fixed to amiddle of the spine that create one or more treatment zones to correctan apex curvature, while allowing and guiding growth and maintaining aconstant force on vertebrae V. In another example, spinal construct 12can have one or more bodies, as described herein, fixed to a middle ofthe spine that create one or more treatment zones to facilitatederotation of vertebrae V. Spinal construct 12 is disposed in a selectedorientation with vertebrae V1, V2 in connection with the surgicalcorrection procedure. In some embodiments, one or more spinal constructs12 are disposed in a linear orientation along vertebrae V. In someembodiments, one or more spinal constructs 12 are disposed withvertebrae V in alternate orientations relative to each other, such as,for example, parallel, perpendicular, adjacent, co-axial, arcuate,offset, staggered, transverse, angular and/or relativeposterior/anterior orientations and/or at alternate vertebral levels.

In some embodiments, spinal correction system 10 comprises spinalconstructs 12 disposed in a bilateral configuration. For example, abilateral configuration can include a first spinal construct 12 affixedto a convex side of each of a plurality of vertebrae V and a secondspinal construct 12 affixed to a concave side of each of a plurality ofvertebrae V. This configuration prevents growth of vertebrae V of theconvex side of the spine while allowing for growth and adjustments tothe concave side for the correction treatment.

Pilot holes are made in vertebrae V1, V2 of vertebrae V in the selectedorientation. Bone fasteners 120, as described herein, are aligned withthe pilot holes and fastened with the tissue of vertebrae V1, V2. Thecomponents of spinal construct 12 are connected with bone fasteners 120and disposed in the selected orientation with vertebrae V1, V2.

End 34 of rod 30 is fixed with bone fastener 120 disposed with vertebraV1. Rod 50 is connected with sleeve 14, as described herein, andmanipulated to a desired tensioning along vertebrae V. Spinal construct12 is connected with vertebrae V1, V2 in connection with the correctiontreatment to facilitate displacing, pulling, twisting and/or aligningvertebrae V as part of spinal correction system 10. End 52 of rod 50 isfixed with bone fastener 120 disposed with vertebra V2 such that spinalconstruct 12 is disposed in a linear orientation along vertebrae V.

Rod 50 translates, in the direction shown by arrow A in FIG. 2, toexpand spinal construct 12 under the bias force of spring 62 to providea constant pressure to rod 50 for growth guidance and distraction.During growth, biasing member 60 and/or spring 94 react to allow dynamictranslation of rod 50 to facilitate growth guidance of spinal construct12. Rod 50 is dynamically axially translatable relative to sleeve 14within passageway 42. Dynamic translation of rod 50 allows spinalconstruct 12 to respond to an active and/or changing spine. As forcesand/or force changes are applied to spinal construct 12, for example,patient growth, trauma and degeneration, and/or spinal correction system10 component creep, deformation, damage and degeneration, rod 50,biasing member 60 and/or spring 94 adapt with a responsive force tomaintain the applied force on vertebrae V substantially constant. Thebiasing force of spring 62 facilitates a self-distracting spinalconstruct 12. Translation of rod 50 allows spinal construct 12 toselectively adjust its length to accommodate growth to avoid multiplesurgeries.

In some embodiments, the components of spinal correction system 10, suchas, for example, spinal construct 12, sleeve 14, biasing member 60,spring 94 and/or rods 30, 50, are configured to provide dynamicallyresponsive movement in response to motion of the spine and adjacentanatomical portions due to factors, such as, for example, growth,trauma, aging, natural load bearing and dynamic characteristics of thespine, which may include flexion, extension, rotation and lateralbending, and/or external loads, which may include axial, shear, linear,non-linear, angular, torsional, compressive and/or tensile loads appliedto the body of a patient. Lock 70 resists and/or prevents translation ofrod 50 relative to sleeve 14, in the direction shown by arrows B in FIG.2 and/or compression/contraction of the components of spinal construct12, as described herein.

In some embodiments, the components of spinal correction system 10, suchas, for example, spinal construct 12, sleeve 14, biasing member 60,spring 94 and/or rods 30, 50, include force sensors configured tomeasure the force on the spine and provide feedback to the surgeon. Insome embodiments, rods 30, 50 have a low friction/low wear material toeliminate wear debris during expansion and contraction.

In some embodiments, spinal correction system 10 includes an agent, forexample, which may be disposed, packed, coated or layered within, on orabout the components and/or surfaces of spinal correction system 10. Insome embodiments, the agent may include bone growth promoting material,such as, for example, bone graft to enhance fixation of the componentsand/or surfaces of spinal correction system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

Upon completion of a procedure, the surgical instruments and/or tools,assemblies and non-implanted components of spinal correction system 10are removed and the incision(s) are closed. One or more of thecomponents of spinal correction system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal correction system10. In some embodiments, spinal correction system 10 may include one ora plurality of rods, plates, connectors and/or bone fasteners for usewith a single vertebral level or a plurality of vertebral levels.

In some embodiments, the components of spinal correction system 10 maybe employed to treat progressive idiopathic scoliosis with or withoutsagittal deformity in either infantile or juvenile patients, includingbut not limited to prepubescent children, adolescents from 10-12 yearsold with continued growth potential, and/or older children whose growthspurt is late or who otherwise retain growth potential. In someembodiments, the components of spinal correction system 10 and methodsof use may be used to prevent or minimize curve progression inindividuals of various ages.

In one embodiment, as shown in FIG. 5, spinal correction system 10,similar to the systems and methods described herein, comprises a spinalconstruct 212, similar to spinal construct 12 described herein. Spinalconstruct 212 includes a sleeve 214, similar to sleeve 14 describedherein, having an inner surface 240 that defines a passageway 242.Passageway 242 includes an opening 244 adjacent an end 216. Passageway242 and opening 244 are configured for movable disposal of spinal rod 50described herein. Rod 50 is dynamically translatable within passageway242 relative to sleeve 214, similar to that described herein.

Rod 50 is configured for connection with a biasing member 260, similarto biasing member 60 described herein. Biasing member 260 includes ahigh pressure chamber 261 and a low pressure chamber 262. Biasing member260 includes a wall 264 that is connected with low pressure chamber 262and end 54 of rod 50. In some embodiments, wall 264 comprises a pistondisposed with low pressure chamber 262.

Biasing member 260 includes a fluid F, such as, for example, apressurized biomaterial and/or a pressurized expanding medium that isdisposed with high pressure chamber 261 and configured to flow and/orexpand from chamber 261 to low pressure chamber 262 via a one-way valve266. Valve 266 is configured to allow transfer of fluid F from highpressure chamber 261 to low pressure chamber 262, and to resist and/orprevent transfer of fluid F from low pressure chamber 262 to highpressure chamber 261. In some embodiments, valve 266 resists and/orprevents transfer of fluid F from low pressure chamber 262 to highpressure chamber 261 such that spinal construct 212 is self-locking.Pressurized fluid F maintains a constant pressure and/or force appliedto wall 264, as described herein, including during relative translationof rod 50, which may modify or increase a volume of chamber 262. In someembodiments, fluid F may include silicone, injectable polymer, sterilewater, saline, inflating air and/or other fluids and gases, and/orcombinations thereof. In some embodiments, fluid F is introduced fromhigh pressure chamber 261 to low pressure chamber 262 via valve 266 at apressure in a range of 3 pounds per square inch (psi) to 5000 psi. Insome embodiments, fluid F may be introduced from high pressure chamber261 to low pressure chamber 262 via valve 266 at constant or variedpressure. In some embodiments, valve 266 is movable between a ventposition and a seal position to facilitate transfer of fluid F.

Wall 264 is configured for moveable disposal within sleeve 214 anddriven or urged in a selected direction under the bias force ofpressurized fluid F disposed with low pressure chamber 262 to facilitatetranslation of rod 50, as described herein. Pressurized fluid F disposedwith low pressure chamber 262 applies a force to wall 264 causing wall264 to drive and/or urge rod 50 in a direction, as shown by arrow AA inFIG. 5. In some embodiments, pressurized fluid F facilitates dynamictranslation of rod 50 during growth, as described herein. Dynamictranslation of rod 50 allows spinal construct 212 to respond to anactive and/or changing spine. For example, as forces and/or forcechanges are applied to spinal construct 212, such as, for example,patient growth, trauma and degeneration, and/or spinal correction system10 component creep, deformation, damage and degeneration, one or morecomponents of spinal construct 212, for example, sleeve 214, rod 50 andbiasing member 260 adapt with a responsive force to maintain the appliedforce transmitted from the bone fasteners substantially constant. Insome embodiments, spinal construct 212 includes biasing member 260 andlock 70 disposed with surface 240, similar to that described herein.

In one embodiment, as shown in FIGS. 6 and 7, spinal correction system10, similar to the systems and methods described herein, comprises aspinal construct 312, similar to spinal construct 12 described herein.Spinal construct 312 includes one or more components, as describedherein, disposed in a selected orientation, as described herein, toguide growth along a selected path and/or orientation along vertebrae,while maintaining a load on vertebrae. In some embodiments, one or morecomponents of spinal construct 312 are disposed in a selectedorientation with vertebrae in connection with a surgical correctionprocedure to create one or more zones of treatment along vertebrae,similar to that described herein.

Spinal construct 312 includes a body having a sleeve 314, similar tosleeve 14 described herein. Sleeve 314 defines a longitudinal axis X2.Sleeve 314 extends between an end 316 and an end 318. The body of spinalconstruct 312 includes a rod 330, similar to rod 30 described herein,extending from end 318. Rod 330 extends between an end 332 and an end334. An outer surface 320 of sleeve 314 tapers between end 318 and rod330 such that rod 330 includes a smaller dimension, such as, forexample, a diameter in thickness than sleeve 314. End 334 is configuredfor disposal with a passageway of a sleeve 414, similar to sleeve 14described herein.

Sleeve 314 includes an inner surface (not shown) that defines apassageway (not shown), similar to passageway 42, as described herein.The passageway of sleeve 314 is configured for movable disposal of rod50, as described herein. Rod 50 is configured to translate within thepassageway relative to sleeve 314, similar to that described herein. Rod50 is engageable with a lock (not shown), similar to lock 70 describedherein, to resist and/or prevent translation of rod 50 relative tosleeve 314. End 54 is configured for disposal within the passageway ofsleeve 314. End 54 is configured for connection with a biasing member(not shown), similar to biasing member 60 described herein.

Spinal construct 312 includes sleeve 414, which defines a longitudinalaxis X3. Sleeve 414 extends between an end 416 and an end 418. Sleeve414 includes an inner surface (not shown) that defines a passageway (notshown), similar to passageway 42 described herein. The passageway ofsleeve 414 is configured for movable disposal of rod 330, similar tothat described herein. Rod 330 is engageable with a lock (not shown),similar to lock 70 described herein, disposed with sleeve 414 to resistand/or prevent translation of rod 330 relative to sleeve 414.

Sleeve 414 includes a rod 450, similar to rod 30 described herein,extending from end 418. Rod 450 extends between an end 452 and an end454. An outer surface 420 of sleeve 414 tapers between end 418 and rod450 such that rod 450 includes a smaller diameter than sleeve 414. End454 is configured for engagement with tissue and/or a spinal implant,such as, for example, a bone fastener, similar to that described herein.

Spinal construct 312 is disposed in a selected orientation, for example,sleeves 314, 414 are oriented in sequence and/or a serial configurationto guide growth along a selected path and/or orientation alongvertebrae, while maintaining a load on vertebrae in connection with asurgical correction procedure, similar to that described herein. Sleeve314 is oriented in series with sleeve 414 such that axis X2 is inalignment with axis X3, as shown in FIG. 7. In some embodiments, sleeves314, 414 are disposed in a serial orientation to create a treatment zonethat extends a length of spinal construct 312, increases force or forceresistance to vertebrae and/or allows for rod contouring of thecomponents of spinal construct 312.

Rods 50, 330 are configured for dynamic translation during growth,similar to that described herein. Dynamic translation of rods 50, 330,in the same direction, as shown by arrows C in FIG. 7, allows spinalconstruct 312 to provide concurrent extension and/or expansion of itscomponents and respond to an active and/or changing spine, similar tothat described herein. In some embodiments, the biasing members disposedwith sleeves 314, 414 are configured with different spring forces and/orrates to create treatment zones. In some embodiments, the treatmentzones can comprise a zone that facilitates distraction of a first regionof spinal construct 12 disposed adjacent, for example, a thoracicportion of the spine at a first rate and a zone that facilitatesdistraction of a second region of spinal construct 12 disposed adjacent,for example, a lumbar portion of the spine at a second, different rate.In some embodiments, the zones provide a varied rate of distraction inthe same direction, as shown by arrows C in FIG. 7. In some embodiments,this configuration resists and/or prevents kyphosis. In someembodiments, rod 50 may include a different material from rod 330 and/orrod 450 to create treatment zones that alter a stiffness of spinalconstruct 312, for example, spinal construct 312 may be more flexibleadjacent rod 50.

In one embodiment, as shown in FIGS. 8-10, spinal correction system 10,similar to the systems and methods described herein, comprises a spinalconstruct 512, similar to spinal construct 12 described herein. Spinalconstruct 512 includes one or more components, as described herein,disposed in a selected orientation, as described herein, to guide growthalong a selected path and/or orientation along vertebrae, whilemaintaining a load on vertebrae. In some embodiments, one or morecomponents of spinal construct 512 are disposed in a selectedorientation with vertebrae in connection with a surgical correctionprocedure to create one or more zones of treatment along vertebrae,similar to that described herein.

Spinal construct 512 includes a body having a sleeve 514, similar tosleeve 14 described herein. Sleeve 514 defines a longitudinal axis X5.Sleeve 514 extends between an end 516 and an end 518. The body of spinalconstruct 512 includes a rod 530, similar to rod 30 described herein,extending from end 518. Rod 530 extends between an end 532 and an end534. End 532 is monolithically formed with sleeve 514. End 534 isconfigured for connection with a sleeve 614, similar to sleeve 14described herein.

Sleeve 514 includes an inner surface (not shown) that defines apassageway (not shown), similar to passageway 42 described herein. Thepassageway of sleeve 514 is configured for movable disposal of rod 50described herein. Rod 50 is configured to translate within thepassageway relative to sleeve 514, similar to that described herein. Rod50 is engageable with a lock (not shown), similar to lock 70 describedherein, to resist and/or prevent translation of rod 50 relative tosleeve 514. End 54 is configured for disposal within the passageway ofsleeve 514. End 54 is configured for connection with a biasing member(not shown), similar to biasing member 60 described herein.

Spinal construct 512 includes sleeve 614, which defines a longitudinalaxis X6. Sleeve 614 extends between an end 616 and an end 618. End 534of rod 530 extends from end 616. End 534 is monolithically formed withsleeve 614. In some embodiments, rod 530 is integrally connected orincludes fastening elements for connection with sleeve 614. An outersurface 620 of sleeve 614 tapers between end 618 and rod 530 such thatrod 530 includes a smaller diameter than sleeve 614.

Sleeve 614 includes an inner surface that defines a passageway (notshown), similar to passageway 42 described herein. The passageway ofsleeve 614 is configured for movable disposal of a rod 650, similar torod 50 described herein. Rod 650 extends between an end 652 and an end654. End 652 is engageable with a lock (not shown), similar to lock 70described herein, to resist and/or prevent translation of rod 650relative to sleeve 614. End 654 is configured for engagement with tissueand/or a spinal implant, such as, for example, a bone fastener, asdescribed herein.

End 652 is configured for disposal within the passageway of sleeve 614.End 652 is configured for connection with a biasing member (not shown),similar to biasing member 60 described herein. Rod 650 is configured totranslate within the passageway relative to sleeve 614.

Spinal construct 512 is disposed in a selected orientation, for example,sleeves 514, 614 are oriented in opposing relation to guide growth alonga selected path and/or provide opposed distraction along vertebrae,while maintaining a load on vertebrae in connection with a surgicalcorrection procedure, similar to that described herein. Sleeve 514 isoriented in opposing relation with sleeve 614 such that axis X5 is inalignment with axis X6, as shown in FIG. 9. Rods 50, 650 are configuredfor dynamic translation during growth, similar to that described herein.Dynamic translation of rods 50, 650, in opposing directions, as shown byarrows D in FIG. 9, allows spinal construct 512 to create a treatmentzone that provides opposed distraction and/or expansion of itscomponents and responds to an active and/or changing spine, similar tothat described herein.

In one example, bone fasteners 120 are engaged with vertebrae includingfixation adjacent an apex A of a spinal curvature, as shown in FIG. 10.Spinal correction system 10 is disposed in a bilateral configurationincluding, such as, for example, a spinal construct 512 and a spinalconstruct 512 a. Spinal construct 512 a is affixed to a convex side CXof each of a plurality of vertebrae. Spinal construct 512 is affixed toa concave side CA of each of a plurality of vertebrae. Thisconfiguration prevents growth of vertebrae of convex side CX of thespine while allowing for growth and adjustments to concave side CA for acorrection treatment to treat various spine pathologies, such as, forexample, adolescent idiopathic scoliosis and Scheuermann's kyphosis.

Spinal constructs 512, 512 a are disposed in a selected orientation suchthat each of spinal constructs 512, 512 a includes sleeves 514, 614oriented in opposing relation to guide growth along a selected pathand/or provide opposed distraction along vertebrae, while maintaining aload on vertebrae in connection with a surgical correction procedure, asdescribed herein. The opposing forces of the biasing members of sleeves514, 614, as described herein, create treatment zones that facilitatecorrection of vertebrae adjacent apex A, while guiding growth. Dynamictranslation of rods 50, 650, as described herein, allows spinalconstructs 512, 512 a to respond to an active and/or changing spine. Insome embodiments, rods 50, 650 may be keyed to sleeves 514, 614 tofacilitate derotation of vertebrae. In some embodiments, spinalconstructs 512, 512 a include a pre-selected curvature having a selectedkyphotic curve, which may include curvature in a sagittal plane.

In one embodiment, as shown in FIGS. 11 and 12, spinal correction system10, similar to the systems and methods described herein, comprises aspinal construct 712, similar to spinal construct 12 described herein.Spinal construct 712 includes a body having a sleeve 714, similar tosleeve 14 described herein. Sleeve 714 extends between an end 716 and anend 718. The body of spinal construct 712 includes a rod (not shown),similar to rod 30 described herein. Sleeve 714 defines a passageway 742,similar to passageway 42 described herein. Passageway 742 is configuredfor movable disposal of rod 50 described herein. Rod 50 is configured totranslate within passageway 742 relative to sleeve 714 via a biasingmember 760, similar to biasing member 60 described herein, and isengageable with a lock 770, similar to lock 70 described herein.

Sleeve 714 includes a surface 750 that defines an opening 752. Opening752 is configured for engagement with a release member, such as, forexample, a set screw 754. Set screw 754 is engageable with sleeve 714and rod 50 to dispose spinal construct 712 in a selected configuration,setting and/or position. Set screw 754 is engageable with a surface ofrod 50 to facilitate delivery of spinal construct 712 to a surgical sitesuch as an operating room, back table, medical facility and/or with apatient body. Set screw 754 is threadably engageable with sleeve 714 toconnect, attach, fix and/or lock, provisionally, removably and/orpermanently, rod 50 to sleeve 714 in a selected configuration, settingand/or position of spinal construct 712.

For example, spinal construct 712 can be disposed in a selectedconfiguration, setting and/or position for delivery of spinal construct712 to a surgical site. Rod 50 is contracted, collapsed and/orcompressed with biasing member 760 within sleeve 714 to dispose spinalconstruct 712 in a contracted, collapsed and/or compressedconfiguration. Set screw 754 is engaged with sleeve 714 and rod 50 toprovisionally fix rod 50 in a non-expandable, contracted, collapsedand/or compressed configuration relative to sleeve 714 for delivery ofspinal construct 712 to a surgical site. In some embodiments, set screw754 may engage the components of spinal construct 712 in a friction fit,pressure fit, interference, mating engagement, interlock and/oradhesive. Spinal construct 712 is attached with vertebrae, similar tospinal construct 12 described herein. Set screw 754 is rotated,disengaged and/or removed from the components of spinal construct 712intra-operatively in a controlled manner to avoid unexpected forcesbeing applied to the vertebrae. In some embodiments, set screw 754 maydisengage or be removed from the components of spinal construct 712gradually. Disengagement or removal of set screw 754 from the componentsof spinal construct 712 releases spinal construct 712 from the selectedconfiguration, setting and/or position to activate and/or release rod 50such that rod 50 can dynamically translate and/or expand spinalconstruct 712, similar to that described herein. In some embodiments,spinal correction system 10 includes a release mechanism engageable withthe components of spinal construct 712 and is resorbable at precise timeperiods to initiate a next phase of growth of vertebrae.

In one embodiment, as shown in FIG. 13, spinal correction system 10,similar to the systems and methods described herein, comprises a spinalconstruct 812, similar to spinal construct 12 described herein. Spinalconstruct 812 includes a body having a sleeve 814, similar to sleeve 14described herein. Sleeve 814 extends between an end 816 and an end 818.The body of spinal construct 812 includes a rod (not shown), similar torod 30 described herein. Sleeve 814 defines a passageway 842, similar topassageway 42 described herein. Passageway 842 is configured for movabledisposal of a rod 850, similar to rod 50 described herein. Rod 850 isconfigured to translate within passageway 842 relative to sleeve 814,similar to that described herein.

Rod 850 extends between an end 852 and an end 854. End 854 is configuredfor disposal within passageway 842. End 854 includes a surface 858configured for connection with a biasing member 860, similar to biasingmember 60 described herein. Biasing member 860 includes a coil spring862 and a follower 864. Follower 864 is configured for moveable disposalwithin sleeve 814 and driven or urged in a selected direction under thebias force of spring 862 to facilitate translation of rod 850.

Follower 864 includes a surface 866 that is threaded with a surface 868of sleeve 814 to comprise a release member of spinal construct 812.Surface 866 is threaded with sleeve 814 in a selected configuration,setting and/or position to facilitate delivery of spinal construct 812to a surgical site such as an operating room, back table, medicalfacility and/or with a patient body. Surface 866 is threaded with sleeve814 to connect, attach, fix and/or lock, provisionally, removably and/orpermanently, rod 50 to sleeve 814 in a selected configuration, settingand/or position of spinal construct 812.

For example, spinal construct 812 can be disposed in a selectedconfiguration, setting and/or position for delivery of spinal construct812 to a surgical site. Rod 50 is contracted, collapsed and/orcompressed with biasing member 860 within sleeve 814 to dispose spinalconstruct 812 in a contracted, collapsed and/or compressedconfiguration. Surface 866 is engaged with sleeve 814 in a configurationwith rod 50 to provisionally fix rod 50 in a non-expandable, contracted,collapsed and/or compressed configuration relative to sleeve 814 fordelivery of spinal construct 812 to a surgical site. Spinal construct812 is attached with vertebrae, similar to spinal construct 12 describedherein. Surface 866 is rotated to disengage surfaces 866, 868intra-operatively in a controlled manner to avoid unexpected forcesbeing applied to the vertebrae and allow relative movement of rod 50 andsleeve 814. Disengagement of surfaces 866, 868 releases spinal construct812 from the selected configuration, setting and/or position to activateand/or release rod 50 such that rod 50 can dynamically translate and/orexpand spinal construct 812, similar to that described.

In one embodiment, as shown in FIGS. 14-16, spinal correction system 10,similar to the systems and methods described herein, comprises a spinalconstruct 912, similar to spinal construct 12 described herein. Spinalconstruct 912 includes a body having a sleeve 914, similar to sleeve 14described herein.

Sleeve 914 defines a longitudinal axis X9. Sleeve 914 extends between anend 916 and an end 918. The body of spinal construct 912 includes a rod930 extending from end 918. Rod 930 extends between an end 932 and anend 934. In some embodiments, end 932 is monolithically formed withsleeve 914. End 934 is configured for engagement with tissue and/or aspinal implant, such as, for example, a bone fastener, as describedherein.

Sleeve 914 includes a surface 940 that defines a passageway 942, similarto passageway 42 described herein. Passageway 942 extends axially withinsleeve 914. Passageway 942 includes an opening 944 adjacent end 916.Passageway 942 and opening 944 are configured for movable disposal of aspinal rod 950, similar to rod 50 described herein. Rod 950 isconfigured to translate within passageway 942 relative to sleeve 914, asdescribed herein. In some embodiments, rod 950 is configured for dynamicaxial translation relative to sleeve 914, as described herein. Surface940 defines a cavity 946 for disposal of a portion of a lock 970,similar to lock 70 described herein.

Rod 950 extends between an end 952 and an end 954. Rod 950 includes asurface 956 engageable with an inner surface of lock 970 to facilitatetranslation of rod 950 relative to sleeve 914 in a first direction andto resist and/or prevent translation of rod 950 in a second direction,as described herein. End 952 is configured for engagement with tissueand/or a spinal implant, such as, for example, a bone fastener, asdescribed herein. End 954 is configured for disposal within passageway942. End 954 includes a surface 958 configured for connection with aportion of lock 970, as shown in FIG. 16.

A biasing member 960, similar to biasing member 60 described herein,includes a spring 962 and a follower 964. Follower 964 is configured formoveable disposal within sleeve 914 and driven or urged in a selecteddirection under the bias force of spring 962 to facilitate translationof rod 950, as described herein. In some embodiments, such translationof rod 950 includes expansion of spinal construct 912 under the biasforce of spring 962 to provide a constant pressure to rod 950 for growthguidance and distraction.

In some embodiments, follower 964 includes a surface 965. Surface 965defines a cavity 967 configured for disposal of a portion of lock 970,as described herein. In some embodiments, follower 964 includes openings1000 configured for disposal of bearings 1002. Bearings 1002 areconfigured to roll and/or slide between surface 940 and a taperedportion 1016 of lock 970 to facilitate translation of rod 950 relativeto sleeve 914, and/or expansion of the components of spinal construct912, as described herein.

Spring 962 is disposed within sleeve 914 and extends between a surface963 of sleeve 914 and a surface 968 of follower 964. In someembodiments, spring 962 extends about an extension 969 of follower 964.Spring 962 applies a force and/or load to surface 968 causing follower964 to drive and/or urge rod 950, as described herein. As such, rod 950is urged to expand spinal construct 912 under a constant force of spring962. In some embodiments, spring 962 facilitates dynamic translation ofrod 950 during growth. Dynamic translation of rod 950 allows spinalconstruct 912 to respond to an active and/or changing spine.

For example, as forces and/or force changes are applied to spinalconstruct 912, such as, for example, patient growth, trauma anddegeneration, and/or system 10 component creep, deformation, damage anddegeneration, one or more components of spinal construct 912, forexample, sleeve 914, rod 950 and biasing member 960 adapt and/or arecontinuously adjustable with a responsive force to maintain the appliedforce transmitted from the bone fasteners substantially constant.

In some embodiments, the dynamic biasing force of spring 962 facilitatesa self-distracting spinal construct 912. Translation of rod 950 allowsspinal construct 912 to selectively adjust its length to accommodategrowth to avoid multiple surgeries. In some embodiments, spinalconstruct 912 includes one or more components, as described herein,disposed in a selected orientation, as described herein, to guide growthalong a selected path, while maintaining a load on the spine.

Lock 970 includes a sleeve 972 having an inner surface 974 that definesa cavity 976. Rod 950 is configured for disposal within cavity 976. Insome embodiments, rod 950 is connected with sleeve 972 and includesbearings 973 to facilitate relative rotation of rod 950, as shown inFIG. 16. Sleeve 972 includes a surface 978 that includes an extension980. Extension 980 is configured for disposal with a locking member1010. Member 1010 includes an extension 1012 and a receiver 1014.Extension 1012 is configured for disposal with cavity 967. Receiver 1014includes tapered portion 1016 configured for engagement with bearings1002, as described herein. In some embodiments, tapered portion 1016 mayinclude a constant taper throughout a length. In some embodiments,tapered portion 1016 extends along a discrete length of receiver 1014.In some embodiments, tapered portion 1016 includes a substantiallycontinuous slope, or may include different slopes along the length.

Lock 970 includes a biasing member, such as, for example, a coil spring994, as shown in FIG. 16. Spring 994 is disposed within cavity 967.Spring 994 applies a force and/or load to a surface 1018 of member 1010.In some embodiments, spring 994 stabilizes motion and/or positions lock970 with passageway 942. In some embodiments, spring 994 causes lock 970to drive and/or urge rod 950, as described herein. As such, in thenon-locked orientation rod 950 is urged to expand spinal construct 912under a constant force of springs 962, 994. In some embodiments, springs962, 994 facilitate dynamic translation of rod 950 during growth.Dynamic translation of rod 950 allows spinal construct 912 to respond toan active and/or changing spine.

Upon compression and/or contraction of the components of spinalconstruct 912, bearings 1002 slide/roll into a more narrow space betweensurfaces 1016 and 940 for an interference and/or frictional engagementtherewith to compress and/or crimp rod 950 with tapered portion 1016 toresist and/or prevent translation of rod 950 relative to sleeve 914and/or compression/contraction of the components of spinal construct912, as described herein. In some embodiments, translation of rod 950relative to sleeve 914 and/or compression/contraction of the componentsof spinal construct 912 is resisted and/or prevented in a lockedorientation of spinal construct 912. In some embodiments, lock 970 isdisengageable or removable from a locked orientation. In someembodiments, lock 970 is fixed in a locked orientation.

In some embodiments, spinal construct 912 prevents axial migration ofrod 950 while maintaining a dynamically movable configuration of rod950. In some embodiments, rod 950 may include a dynamically axiallytranslatable configuration, as described herein, and spinal construct912 may be configured, as described herein, such that spinal construct912 may limit, resist and/or prevent movement in at least one directionof rod 950 relative to sleeve 914. Movement of bearings 1002 alongtapered portions 1016 facilitates locking and unlocking of lock 970relative to rod 950.

In some embodiments, member 1010 includes a surface 1020 that defines aslot 1022. In some embodiments, slot 1022 is configured for engagementwith a pin 996 to connect sleeve 914 with lock 970. In some embodiments,pin 996 and slot 1022 are configured to guide movement of rod 950 and/orlock 970. In some embodiments, pin 996 and slot 1022 define a range ofmovement of translation of member 1010.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A spinal construct comprising: at least one bodyincluding a first biasing member engageable with a longitudinal elementfor translation thereof relative to the body in a first direction and asecond biasing member engageable with a lock, the lock being connectedwith the longitudinal element to resist and/or prevent translation ofthe longitudinal element relative to the body in a second direction. 2.A spinal construct as recited in claim 1, wherein the first biasingmember includes a follower and a spring disposed thereabout, the springapplying a force to the follower such that the follower translates thelongitudinal element in the first direction.
 3. A spinal construct asrecited in claim 1, wherein the first biasing member and the lockcomprise a strut to resist and/or prevent translation of thelongitudinal element in the second direction.
 4. A spinal construct asrecited in claim 1, wherein the longitudinal element includes a firstend connected with vertebral tissue and a second end connected with thebiasing member such that the second end is continuously adjustablerelative to the body.
 5. A spinal construct as recited in claim 1,wherein the longitudinal element includes a first end connected withvertebral tissue and a second end connected with the biasing member suchthat the second end is dynamically translatable relative to the body. 6.A spinal construct as recited in claim 1, wherein the body includes aninner surface having a tapered portion engageable with the lock in acrimp configuration.
 7. A spinal construct as recited in claim 1,wherein the lock includes a plurality of spaced apart bearingsengageable with the body to resist and/or prevent translation of thelongitudinal element relative to the body in the second direction.
 8. Aspinal construct as recited in claim 1, wherein the at least one bodyincludes a plurality of bodies disposed in a selected orientation withtissue to create at least one zone of treatment with the tissue.
 9. Aspinal construct as recited in claim 8, wherein the at least one zone oftreatment includes a first rate of distraction of a first region of thespinal construct and a second different rate of distraction of a secondregion of the spinal construct.
 10. A spinal construct as recited inclaim 8, wherein the at least one zone of treatment includes opposeddistraction of vertebrae.
 11. A spinal construct as recited in claim 8,wherein the at least one zone of treatment includes a plurality ofbodies having alternate flexibility.
 12. A spinal construct as recitedin claim 1, further comprising a release mechanism engageable with theat least one body and the longitudinal element to fix the longitudinalelement in a non-expandable and/or compressed orientation relative tothe at least one body.
 13. A spinal construct as recited in claim 12,wherein the release mechanism is disengageable from the at least onebody and the longitudinal element intra-operatively.
 14. A spinalconstruct as recited in claim 1, wherein the first biasing memberincludes a fluid.
 15. A spinal construct as recited in claim 1, whereinthe first biasing member includes a low pressure chamber and a highpressure chamber connected by a one direction valve.
 16. A spinalconstruct comprising: a sleeve including a follower and a springdisposed thereabout, the spring applying a force to the follower suchthat the follower translates a rod relative to the sleeve in a firstaxial direction; and a lock spring engageable with a lock disposed withthe sleeve, the lock being connected with the rod to resist and/orprevent translation of the rod relative to the sleeve in a second axialdirection.
 17. A spinal construct comprising: a body including a firstsleeve having a biasing member engageable with a first longitudinalelement for translation thereof relative to the first sleeve in a firstdirection and a lock spring engageable with a lock, the lock beingconnected with the first longitudinal element to resist and/or preventtranslation of the first longitudinal element relative to the firstsleeve in a second direction, and a second sleeve having a biasingmember engageable with a second longitudinal element for translationthereof relative to the second sleeve in the second direction and a lockspring engageable with a lock, the lock of the second sleeve beingconnected with the second longitudinal element to resist and/or preventtranslation of the second longitudinal element relative to the secondsleeve in the first direction.
 18. A spinal construct as recited inclaim 17, wherein the body is attachable with an apical portion ofvertebrae.
 19. A spinal construct as recited in claim 17, wherein thefirst longitudinal element is attachable with first vertebral tissue viaat least one bone fastener and the second longitudinal element isattachable with second vertebral tissue via at least one bone fastenersuch that the body is attachable with an apical portion of vertebrae.20. A spinal construct as recited in claim 17, wherein the firstlongitudinal element is dynamically translatable relative to the body ina first axial direction and the second longitudinal element isdynamically translatable relative to the body in a second axialdirection.